Abstract
Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about the optimal use of medical products in real-world practice. Here, we argue that contrary to widespread impressions, existing FDA regulations embody sufficient flexibility to accommodate the emerging tools and methods needed to achieve this goal.
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References
Sherman, R. E. et al. Real-world evidence – what is it and what can it tell us? N. Engl. J. Med. 375, 2293–2297 (2016).
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Acknowledgements
The authors thank J. McCall of the Duke Clinical Research Institute, Durham, North Carolina, USA, for editorial assistance with this article.
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Competing interests
At the time this manuscript was drafted, R.M.C. was the Commissioner of Food and Drugs, US Food and Drug Administration. Prior to his appointment to the FDA, he received research grant funding from the Patient-Centered Outcomes Research Institute, the National Institutes of Health, the US Food and Drug Administration, Amylin, and Eli Lilly and Company; research grants and consulting payments from Bristol-Myers Squibb, Janssen Research and Development, Merck, and Novartis; consulting payments from Amgen, Bayer Healthcare, BMEB Services, Genentech, GlaxoSmithKline, Heart.org – Daiichi Sankyo, Kowa, Les Laboratoires Servier, Medscape/Heart.org, Regado, and Roche; he also held equity in N30 Pharma and Portola. The other authors have no conflicts of interest to disclose.
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Flexibility of the FDA's historical and current evidence standards (PDF 264 kb)
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Sherman, R., Davies, K., Robb, M. et al. Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nat Rev Drug Discov 16, 297–298 (2017). https://doi.org/10.1038/nrd.2017.25
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DOI: https://doi.org/10.1038/nrd.2017.25
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